Ghana becomes the first country to approve Oxford University’s new malaria vaccine

GHANA – Ghana has become the first country in the world to approve a new malaria vaccine from Oxford University, R21//Matrix-M, with children under the age of three in line to benefit.

Ghana’s drug regulators have assessed the final trial data on the vaccine’s safety and effectiveness, which is not yet public, and have decided to use it, although it is unclear when the rollout will begin.

The World Health Organization is also considering approving the vaccine.

Ghana’s Food and Drugs Authority has approved the vaccine’s use in children aged between five months to three years as the West African country strengthens its efforts to control malaria-related child mortality. Around 20,000 children die of malaria every year in Ghana, 25% of whom are aged under five.

India’s Serum Institute, which is partnering with Oxford University, built a vaccine factory in the country’s capital Accra to produce up to 200 million doses a year.

However, the launch of the vaccine will involve a lot of groundwork in Ghana.

“While the vaccine might be heralded as a huge win in the fight against malaria, it is no silver bullet,” Javier Guzman, the director of global health policy at the Center for Global Development, said.

“There are important points to consider before the R21 vaccine is rolled out for wider use.”

Adar Poonawalla, CEO of the Serum Institute, said: “Developing a vaccine to greatly impact this huge disease burden has been extraordinarily difficult.”

He added that Ghana, as the first country to approve the vaccine, represents a “significant milestone in our efforts to combat malaria around the world”.

Trial data from preliminary studies in Burkina Faso showed the R21 vaccine was up to 80% effective when given as three initial doses, and a booster a year later. The trial is also happening in Kenya, Mali and Tanzania.

More promising than previous vaccine

The vaccine appears to be hugely effective, in stark contrast to previous ventures in the same field.

An earlier vaccine, GlaxoSmithKline’s (GSK) Mosquirix, had an effectiveness rating of about 60% but was approved by WHO since there was no alternative in sight.

It was only 30% effective in preventing severe cases. It required at least four doses to be effective although its effectiveness waned with time.

GSK committed to producing 15 million doses of Mosquirix annually till 2028. But it fell short of the 100 million required for long-term intervention.

Ghana, Kenya and Malawi were all involved in the pilot programme for the roll-out of Mosquirix and have begun introducing it more widely in recent months.

Since it began in 2019, 1.2 million children across the three countries have received at least one dose of the Mosquirix vaccine.

The WHO said last month that in the areas where the vaccine has been given, all-cause child mortality has dropped by 10%, a sign of its impact.

The World Malaria Report cited 247 million cases in 2021 compared to 245 million in 2020.

The estimated number of deaths stood at 619, 000 in 2021, with four African countries accounting for more than half of them: Nigeria (31.3%), the Democratic Republic of Congo (12.6%), Tanzania (4.1%), and Niger (3.9%). Children aged under five accounted for about 80% of these cases in Africa.

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